Tesar 1991.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III panic disorder with or without limited or extensive phobic avoidance Method of diagnosis: Structured Clinical Interview for DSM‐III‐Upjohn version (SCID‐Up) Age: for alprazolam, M = 32.8, SD = 8.9; for clonazepam M = 30.5, SD = 6.5 Sex: for alprazolam 58 female, 42 male; for clonazepam 58 female, 42 male Location: USA; setting unclear Co‐morbidities: patients with bipolar disorder, OCD, psychosis, dementia, substance abuse or major medical disorders were excluded; a concurrent diagnosis of major depression was permissible as long as it was judged to be secondary to panic disorder Rescue medication: not stated |
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Interventions |
Participants were randomly assigned to either: (1) alprazolam arm (n = 24) Duration: 6 weeks Treatment Protocol: flexible dosage, range = 1 ‐ 10 mg, M = 5.39 SD = 2.89 (2) clonazepam arm (n = 26) Duration: 6 weeks Treatment Protocol: flexible dosage, range = 0.5 ‐ 5 mg, M = 2.5 SD = 0.94 (3) placebo arm (n = 22) Duration: 6 weeks |
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Outcomes |
Time points for assessment: weekly Outcomes: 1. Clinical Global Impression Scale (CGI) 2. Patient Global Assessment (PGI) 3. panic attacks frequency 4. phobias 5. Work and Social Disability Scale 6. Beck Depression Inventory (BDI) |
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Notes |
Date of study: not stated Funding source: sponsored by Upjohn Co. Declarations of interest among the primary researchers: none. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the study drugs were administered in identical capsules according to a standardised but flexible dosing schedule". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the study drugs were administered in identical capsules according to a standardised but flexible dosing schedule". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Both endpoint analysis based on LOCF and completers analysis were performed. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Supported in part by a grant from the Upjohn Co.; the role of the funder in planning, conducting and writing the study is not discussed. |